Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT07456852 · ClinicalTrials.gov registry record · Phase 1
Vasodilator Therapy With Isosorbide Mononitrate or Diltiazem to Reduce Vasotoxicity in Patients With Gastrointestinal Cancer Receiving Fluoropyrimidine Therapy
A Phase 1 study, sponsored by Mayo Clinic.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 60
- Enrollment target
NCT07456852: Recruiting Phase 1 study, sponsored by Mayo Clinic.
NCT07456852 is a Phase 1 study that is actively recruiting participants, run by Mayo Clinic. The registered enrollment target is 60 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07456852, a Phase 1 study, is actively recruiting participants, sponsored by Mayo Clinic.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 60 participants
- Enrollment target
Study Summary
This phase I/II trial compares the effect of drugs that causes widening of blood vessels as a result of smooth muscle relaxation (vasodilator therapy) with isosorbide mononitrate, diltiazem or placebo to reduce vasotoxicity in patients with gastrointestinal cancer receiving fluoropyrimidine therapy. Some patients develop chest pain (possibly even a heart attack, a drop in heart function, or a rhythm abnormality) during treatment with a class of cancer drugs known as fluoropyrimidines, which include 5-Fluorouracil (5-FU) and capecitabine. These side effects are believed to be due to the development of an abnormal reactivity of the blood vessels referred to as vasospasm. Vasotoxicity is damage or toxicity inflicted upon blood vessels (vascular system), often causing dysfunction, remodeling, or narrowing (vasoconstriction). It is a broad term used to describe the detrimental effects of certain agents, such as chemotherapy drugs. Researchers want to evaluate how often the reactivity of blood vessels becomes abnormal, during the treatment with 5-FU or capecitabine and how clinically relevant and controllable/preventable this phenomenon is in patients with gastrointestinal cancer.
Interventions
- PROCEDURE Biospecimen Collection
- DRUG Capecitabine
- DRUG Fluorouracil
- PROCEDURE Electrocardiogram
- DRUG Diltiazem Hydrochloride
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2026-04-30 |
| Est. Completion | 2030-04-30 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07456852
The ClinicalTrials.gov registry entry for NCT07456852 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Mayo Clinic, which has 2,844 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT07456852 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT07456852 about?
NCT07456852 is a clinical study titled "Vasodilator Therapy With Isosorbide Mononitrate or Diltiazem to Reduce Vasotoxicity in Patients With Gastrointestinal Cancer Receiving Fluoropyrimidine Therapy". This phase I/II trial compares the effect of drugs that causes widening of blood vessels as a result of smooth muscle relaxation (vasodilator therapy) with isosorbide mononitrate, diltiazem or placebo to reduce vasotoxicity in patients with gastrointestinal cancer receiving fluoropyrimidine therapy....
What is the current status of trial NCT07456852?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 60 participants. The study started on 2026-04-30. Estimated completion is 2030-04-30.
What interventions are being tested in trial NCT07456852?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Capecitabine (DRUG), Fluorouracil (DRUG), Electrocardiogram (PROCEDURE), Diltiazem Hydrochloride (DRUG).
Who is sponsoring clinical trial NCT07456852?
This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, the data changelog, or report a data error.